Ben Goldacre points to an interview in the British Medical Journal where Luisa Dillner talks to Michael Rawlins, the man behind the Academy of Medical Sciences’ review of medical research governance, about current hurdles in getting clinical trials started and what can be done to improve the process:
“Respondents to the review cited two main bottlenecks to starting research projects. One was the Clinical Trials Directive, set up in 2001 to protect trial participants, improve ethical standards of trials across the EU, and harmonise the administration of the governance of clinical research. A public consultation on the effects of this legislation in January 2010 found that it had had some negative consequences, such as increased costs and more administrative hurdles in trials. The European Commission has since said it will revise the legislation.”